With an aging population and their changes in life environment, it is desired to develop an orally-disintegrating solid preparation capable of being administered without water, retaining the convenience for use which is a characteristic of a tablet, and being administered on demand easily, anytime and anywhere, without water.
When the pharmaceutically active ingredient has a bitter taste, masking of the bitter taste by coating is preferable for drug compliance. When the pharmaceutically active ingredient is easily decomposed by an acid, it is necessary to coat the ingredient to prevent decomposition by the gastric acid and ensure sufficient delivery to the intestine. To solve these problems, coated tablets, capsules and the like are generally used.
To meet these requirements, tablets containing coated fine granules have conventionally been developed. For example, JP-A-6-502194 (U.S. Pat. No. 5,464,632) discloses a rapidly disintegratable multiparticular tablet comprising a pharmaceutically active ingredient in the form of coated fine particles and the like. In addition, JP-A-2000-281564 and JP-A-2000-103731 disclose orally-disintegrating tablets containing coated fine granules.
During the production of solid preparations such as tablet containing coated fine granules and the like, however, fine granules may be broken during tabletting as evidenced by partial destruction of a coating layer of fine granules and the like, resulting in problems such as a decreased masking effect on the aforementioned bitter taste, acid resistance and the like.
patent document 1: JP-A-6-502194
patent document 2: JP-A-2000-281564
patent document 3: JP-A-2000-103731